Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description

T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA,
Product Usage:
The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.

Recall Number

Z-2200-2013

Classification

Class II

Code Info

RS12K008

Product Distributed Qty

9 units

Reason For Recall

One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.